MK0991 Versus Amphotericin B for Empirical Therapy in Febrile, Neutropenic Pediatric Patients (0991-044)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2006-10-31

Brief Summary

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This study is a double-blind, randomized study of MK0991 versus liposomal amphotericin B in the empirical treatment of pediatric patients (ages 2 through 17 years) who have an absolute neutrophil count (ANC) below 500/microliter and who have fever despite broad antibiotic coverage. Such patients would be candidates for empirical therapy with an intravenous anti-fungal agent.

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Detailed Description

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Conditions

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Neutropenia Fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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caspofungin acetate

Duration of Treatment: 28-90 days

Intervention Type DRUG

Comparator: AmBisome

Duration of Treatment: 28-90 days

Intervention Type DRUG

Other Intervention Names

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MK0991

Eligibility Criteria

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Inclusion Criteria

* Patients who are 2 through 17 years of age
* Absolute Neutrophil Count (ANC) is below 500/microliter
* Have persistent fever (at least 4 days) despite antibiotic therapy

Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No